Replimune CERPASS trial misses primary endpoints; BLA for RP1 in melanoma planned 2H 2024

Replimune Group, Inc.

CERPASS trial of RP1+cemiplimab in CSCC did not meet primary endpoints; CRR 38.1% vs 25% (p=0.040 just below threshold).
In anti-PD1 failed melanoma (IGNYTE, n=156), ORR 31.4% (12% CR); median DOR >24 months; BLA submission planned for 2H 2024.
RP1 monotherapy (ARTACUS) in transplant patients: 34.8% ORR, 5 CRs, no allograft rejection.
Portfolio reprioritization: discontinue RP2/3 in SCCHN/CRC and RP3 development; focus on RP1 melanoma and RP2 uveal melanoma.
Cash $496.8M as of Sept 30, 2023; cash runway extended into early 2026.

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